510(k) K011532 ยท HDB Extractor, Vacuum, Fetal
MITYVAC
| Applicant | Prism Enterprises, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Jul 30, 2001 |
| Received | May 18, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011532
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Cooper Surgical, Inc. M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use Terminated |
HDB | None listed |
| Sep 17, 2008 | Cooper Surgical, Inc. M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted Delivery System (Ref: 10015LP). Product is intended to assist a clinician in the delivery of an infant during c Terminated |
HDB | None listed |
| Sep 17, 2008 | Cooper Surgical, Inc. Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vagina Terminated |
HDB | None listed |
| Oct 5, 2004 | CooperSurgical, Inc. Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System
Product No: 10047 Terminated |
HDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.